Scaling up TB and HIV Treatment Integration

NCT02654613 | Completed DMC

• 1 other identifier: CAP013
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study addresses the highest ranking health research priority in South Africa, which is, to develop and test optimal models of HIV-TB service delivery that will enhance retention, adherence and coverage of HIV-TB co-infected patients. HIV and TB are highest in sub-Saharan Africa, a region with limited health budgets, infrastructure, human resources, and suboptimal TB infection control practices. There is compelling clinical evidence suggesting that integrating HIV and TB services saves lives and presents an effective and efficient use of resources directed at optimizing health outcomes. Quality improvement (QI) methods are increasingly being used to systematically test and incorporate local ideas into strategies for reliable implementation and scale up. This trial is designed to test a practical, implementable and affordable strategy aimed at improving HIV-TB service integration to reduce TB and HIV associated deaths. This is a cluster randomized controlled trial, which evaluates and tests the effectiveness of implementing a QI model to integrate HIV-TB service delivery in primary health care clinics, on reducing morbidity and mortality in TB-HIV co-infected patients. This study will be conducted in 2 districts, Ugu and uThungulu, in KwaZulu-Natal, South Africa. The model of integrated care delivery for TB and HIV using the QI method offers a systems approach to care delivery to directly enhance treatment outcomes by enabling comprehensive effective care designed around the patients journey from entry to the clinic, through screening treatment initiation, treatment completion, and retention in care that is directed at the goals of cure for TB, effective sustainable HIV viral suppression and reduced HIV associated TB mortality as the main health impact. The scalability of the model, once proven effective, is the critical element that makes it increase population coverage of quality diagnosis and treatment of HIV-TB co-infection. QI methods promote front line staff engagement in identification and rapid testing of local implementation solutions to gaps in performance of processes of care along the steps of the patient journey. Gaps in care are identified through continuous feedback on a core set of indicators collected monthly as routine collection of data.

Conditions

HIV; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality rate in TB-HIV co-infected patients

  12 months

Secondary Outcomes (7)

• HIV testing rates

  12 months

• Intensified Case Finding for TB

  12 Months

• Cotrimoxazole for HIV-TB patients

  12 months

• Retention in HIV-TB patients

  12 months

• ART initiation in HIV-TB co-infected patients

  12 months

Study Arms (2)

Quality Improvement Intervention

ACTIVE COMPARATOR

In intervention clinics, staff will follow QI methodology to undertake a detailed assessment of their HIV-TB care and to prioritize the steps to improve treatment outcomes. A senior nurse will be identified to be the QI champion and will be trained by the study team to fulfil this role. The QI champion in the clinic then provides peer-leadership, mentorship and support for the implementation of the prioritized changes until the checklist is complete and all integrated HIV-TB service components meet the required standard.

Other: Quality Improvement Model of Care

Control Standard of Care

NO INTERVENTION

The control arm will continue with the usual support that is received for HIV-TB service integration

Interventions

Quality Improvement Model of Care OTHER

QI addresses the "how" of program implementation. Technically, QI improves process performance by developing a common simplified view of the components and linkages of integrated care, real-time data feed-back to track system performance, understanding the psychology of system change, and crucially, the iterative testing and incorporation of ideas for performance improvement from the front-line practitioners, managers, and customers in the local context.

Quality Improvement Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• South African Department of Health Primary Health Care Clinics
• ART site
• Supported by BroadReach Healthcare

You may not qualify if:

• Mobile clinics
• Clinics that do not offer ART
• Clinics with only 1 nurse
• Hospitals and Gateway clinics

Sponsors & Collaborators

• Centre for the AIDS Programme of Research in South Africa: lead
• BroadReach Healthcare: collaborator
• Institute for Healthcare Improvement: collaborator

Study Sites (1)

CAPRISA eThekwini Clinical Research Site

Durban, KwaZulu-Natal, 4001, South Africa

Location

Related Publications (5)

• Naidoo K, Zuma NY, Moodley M, Made F, Perumal R, Gengiah S, Ngozo J, Padayatchi N, Nunn A, Karim SA. High mortality among patients with tuberculosis accessing primary care facilities: secondary analysis from an open-label cluster-randomised trial. EClinicalMedicine. 2025 Mar 18;82:103151. doi: 10.1016/j.eclinm.2025.103151. eCollection 2025 Apr.

  PMID: 40166654 DERIVED

• Naidoo K, Gengiah S, Yende-Zuma N, Mlobeli R, Ngozo J, Memela N, Padayatchi N, Barker P, Nunn A, Karim SSA. Mortality in HIV and tuberculosis patients following implementation of integrated HIV-TB treatment: Results from an open-label cluster-randomized trial. EClinicalMedicine. 2022 Feb 12;44:101298. doi: 10.1016/j.eclinm.2022.101298. eCollection 2022 Feb.

  PMID: 35198922 DERIVED

• Gengiah S, Connolly C, Yende-Zuma N, Barker PM, Nunn AJ, Padayatchi N, Taylor M, Loveday M, Naidoo K. Organizational contextual factors that predict success of a quality improvement collaborative approach to enhance integrated HIV-tuberculosis services: a sub-study of the Scaling up TB/HIV Integration trial. Implement Sci. 2021 Sep 17;16(1):88. doi: 10.1186/s13012-021-01155-7.

  PMID: 34535170 DERIVED

• Gengiah S, Barker PM, Yende-Zuma N, Mbatha M, Naidoo S, Taylor M, Loveday M, Mhlongo M, Jackson C, Nunn AJ, Padayatchi N, Karim SSA, Naidoo K. A cluster-randomized controlled trial to improve the quality of integrated HIV-tuberculosis services in primary healthcareclinics in South Africa. J Int AIDS Soc. 2021 Sep;24(9):e25803. doi: 10.1002/jia2.25803.

  PMID: 34498370 DERIVED

• Naidoo K, Gengiah S, Yende-Zuma N, Padayatchi N, Barker P, Nunn A, Subrayen P, Abdool Karim SS. Addressing challenges in scaling up TB and HIV treatment integration in rural primary healthcare clinics in South Africa (SUTHI): a cluster randomized controlled trial protocol. Implement Sci. 2017 Nov 13;12(1):129. doi: 10.1186/s13012-017-0661-1.

  PMID: 29132380 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Kogieleum Naidoo, MBChB

  Centre for the AIDS Programme of Research in South Africa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 13, 2016
• Study Start: June 1, 2015
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)